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510(k) K801232

JACKSON LACRIMAL INTUBATION SET by Storz Instrument Co. — Product Code HNL

K801232 is an FDA 510(k) premarket notification submitted by Storz Instrument Co. for the device "JACKSON LACRIMAL INTUBATION SET". The FDA issued a decision of Substantially Equivalent on June 17, 1980. The device falls under product code HNL (Probe, Lachrymal), a Class I device regulated under 21 CFR 886.4350. Storz Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1980
Date Received
May 27, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Lachrymal
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Storz Instrument Co.

  • K980100 — STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK (June 1, 1998)
  • K980488 — STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM (March 23, 1998)
  • K972664 — STORZ MILLENNIUM VISCOUS FLUID SYSTEM (October 10, 1997)
  • K971439 — STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES (June 17, 1997)
  • K964743 — STORZ E8010 ERGOTEC/PREMIERE ADAPTOR (February 3, 1997)
  • K960024 — STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE (September 20, 1996)
  • K960061 — STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE (September 18, 1996)
  • K960003 — STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION (August 29, 1996)
  • K962131 — STORZ D4600 AIR EXCHANGE LINE PACK (August 23, 1996)
  • K961874 — STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK (August 6, 1996)

Other clearances for product code HNL

  • K843491 — CONCEPT FIBER OPTIC CANALICULUS INTUBA (October 5, 1984)
  • K840861 — TSE-ANDERSON MODIFIED LACRIMAL GROOV (May 9, 1984)
  • K833671 — STERILE OIL AND GUIDEWIRE (January 10, 1984)
  • K831901 — LACIMAL INTUBATION SETS (July 12, 1983)
  • K813187 — PILLING LACRIMAL INTUBATION SYSTEM (January 28, 1982)
  • K812255 — ETHICON LACRIMAL STENT (August 20, 1981)
  • K802845 — CONCEPT CANALICULUS INTUBATION SET (December 17, 1980)
  • K800089 — CRAWFORD LACRIMAL INTUBATION SET (March 3, 1980)
  • K770194 — NASO-LACRIMAL DUCT INSERT (February 14, 1977)

FDA data resources